在激进化疗后的局部晚期头癌中测量辅助化疗评估 - 一个随机试验
Vijay Patil1, Vanita Noronha1, Nandini Menon1
1Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.
The Lancet regional health. Southeast Asia
|June 29, 2023
概括
口服计量化学疗法与甲状腺和赛莱科西布并没有改善头癌患者在化学辐射后的治疗结果. 在完全反应后,观察仍然是护理标准.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 头部和部癌症 治疗 治疗
背景情况:
- 局部发达的头癌往往在激进化学辐射下有不良结果.
- 口服计量化学疗法在息环境中表现有希望,有限的证据表明在辅助环境中具有潜力.
- 这项研究研究了头癌患者在化学辐射后的口服计量学辅助化疗.
研究的目的:
- 评估口服计量学辅助化疗 (MAC) 在改善头癌患者的整体存活率 (OS) 和无进展存活率 (PFS) 的疗效.
- 为了比较观察和MAC之间的结果,在激进化学辐射治疗后实现完全反应的患者中.
主要方法:
- 一项3期随机研究,涉及137名头部和部癌症患者 (口喉,喉,下喉),在化学辐射后实现了完全反应.
- 患者被随机分为1:1进行观察或18个月的口服计量学辅助化疗 (每周一次甲特雷克萨特和每天一次塞莱科克西布).
- 主要终点是整体存活率 (OS);进行了有效性和徒劳性的计划中期分析.
主要成果:
- 没有进展的3年生存率 (PFS) 在观察中为68.7%,而在计量化疗中为60.8% (P=0.230).
- 三年总生存率 (OS) 在观察中为79.4%,而在计量化疗中为62.4% (P=0.047).
- 与观察相比,口服计量化学疗法没有显著改善PFS或OS.
结论:
- 在这组患者中,口服计量化学疗法 (组合每周使用甲状腺和每天使用切莱科西布) 并没有增强PFS或OS.
- 激进化疗后完全反应后的观察继续是局部发达的头癌的标准护理.
- 可能需要进一步的研究来探索这些具有挑战性的癌症的替代辅助策略.
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